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Yearly Archives: 2020

Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

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March 09, 2020- Roche announced that "we are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III...

Vivli to launch a portal for sharing data from COVID-19 trials

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In a visible sign of data sharing leadership, Vivli, the Center for Clinical Research Data, has committed to serving the open science community through...

Novartis will donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response

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March 20, 2020 - "Novartis announced that its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic...

CryoLife receives CE mark for E-vita Open Neo hybrid stent graft system for the treatment of aortic arch disease

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March 5, 2020: CryoLife has announced that it has received CE mark for E-vita Open Neo, a hybrid stent graft system for the treatment of...

FDA grant Approval For Allergan’s durysta (Bimatoprost Implant) for Open-Angle Glaucoma Or Ocular Hypertension Patients

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March 5, 2020: Allergan announced that the U.S. FDA has approved the company's New Drug Application (NDA) for DURYSTA™ (bimatoprost implant) 10 mcg for intracameral...

U.S. Food and Drug Administration grants Orphan Drug Designation to TG Therapeutics for Umbralisib for the Treatment of Follicular Lymphoma

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March 05, 2020: TG Therapeutics announced that the U.S.FDA granted orphan drug designation to umbralisib, the Company’s investigational dual inhibitor of PI3K-delta and CK1-epsilon, for...

USFDA Grants Rare Pediatric Disease Designation to Stealth BioTherapeutics for Elamipretide for the Treatment of Barth Syndrome

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March 3, 2020: Stealth BioTherapeutics announced that the U.S. FDA has granted Rare Pediatric Disease (RPD) designation for elamipretide for the treatment of Barth...

FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in the Certain Medical Devices with Bluetooth Low Energy

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March 03, 2020: U.S. FDA is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that...

KemPharm Submits KP415 NDA to USFDA for the Treatment of attention deficit hyperactivity disorder (ADHD)

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March 02, 2020: KemPharm announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic...

FDA grants Breakthrough Therapy Designation for Roche’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease

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March 03, 2020: Roche announced that the U.S.FDA has granted Breakthrough Therapy Designation (BTD) to Esbriet® (pirfenidone) for the adults with unclassifiable interstitial lung...

Coronavirus (COVID-19) Update: FDA and CDC take action to increase access to the respirators, including N95s, for the health care personnel

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March 3, 2020: The U.S. FDA and the Centers for Disease Control and Prevention took action to make more respirators, including certain N95s, available...

FDA allows labs margin in testing for coronavirus

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March 1, 2020: The FDA took new steps to expand testing for the coronavirus by allowing certain hospital laboratories in order to use their...
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